BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22363478 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04854
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    February 6, 2019
    Report Date
    June 30, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 6/30/2025, D4: BATCH # UNK, B3: UNKNOWN; CAPTURED AS AWARENESS DATE, D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: RESULT OF 310 CONSECUTIVE PATIENTS UNDERGOING LAPAROSCOPIC NISSEN FUNDOPLICATION AS HOSPITAL OUTPATIENTS OR AT A FREE-STANDING SURGERY CENTER AUTHOR(S): S. RAY CITATION: SURG ENDOSC (2003) 17: 378¿380; DOI: 10.1007/S00464-002-8843-5. THIS STUDY AIMED TO PRESENT THE RESULT OF THE PATIENTS UNDERGOING LAPAROSCOPIC NISSEN FUNDOPLICATION AS AN OUTPATIENT PROCEDURE. OVER A 4-YEAR PERIOD, 310 PATIENTS (N=148 MALE AND N=162 FEMALE; AVERAGE AGE OF 53 YEARS [20-83 YEARS]; AVERAGE WEIGHT OF 185 POUNDS [RANGED 85-324 POUNDS]) WITH GASTROESOPHAGEAL REFLUX DISEASE UNDERWENT LAPAROSCOPIC NISSEN FUNDOPLICATION. IN THE PROCEDURE, SHORT GASTRICS AND GASTROPHRENIC LIGAMENTS WERE DIVIDED BY A 5-MM HARMONIC SCALPEL THUS FACILITATING FULL FUNDIC MOBILITY. CRURAL STITCHES WERE PLACED TO CLOSE THE HIATAL DEFECT WITH THE 0-ETHIBON INTERRUPTED STITCH USING ESS ETHICON SUTURE SYSTEM, ETHICON ENDO-SURGERY, INC., CINCINNATI, OHIO, USA) IN ALL CASES. COMPLICATIONS INCLUDED GASTRIC PERFORATION (N=2) TREATED BY LAPAROSCOPIC CLOSURE OF THE PERFORATION AND UNDERWENT A FULL 360° WRAP; SIGNIFICANT BLEED FROM THE SHORT GASTRIC ARTERY (N=1); INABILITY TO KEEP LIQUIDS DOWN (N=10) WHICH UNDERWENT INTRAVENOUS HYDRATION AND AN ESOPHAGOGASTRODUODENOSCOPY WITH BALLOON DILATION OF THE ESOPHAGOGASTRIC (EG) JUNCTION, RESULTING IN RESOLUTION OF THEIR SYMPTOMS AND ADDITIONALLY IN FOUR PATIENTS POSTOPERATIVE DILATIONS OF THE EG JUNCTION WITHIN 6 MONTHS AFTER THE PROCEDURE; DYSPHAGIA (N=1) TREATED BY REMOVAL OF CRURAL STITCH WITH RESOLUTION OF SYMPTOMS; GASTRIC BLOATING (N=3) TREATED WITH REGLAN 10MG THREE TIMES DAILY WITH SIGNIFICANT SYMPTOMATIC IMPROVEMENT; RECURRENT REFLUX/HEARTNBURN (N=11) TREATED WITH REPEAT LAPAROSCOPIC NISSEN FUNDOPLICATION WITH RESOLUTION OF SYMPTOMS (N=2) AND THE REMAINING NINE CHOSE TO REMAIN ON MEDICATION. ADEQUATE MOBILIZATION OF THE FUNDUS BY DIVIDING THE SHORT GASTRICS AND THE GASTROPHRENIC LIGAMENT IS IMPORTANT IN ACHIEVING A LOOSE WRAP. ATTENTION MUST BE GIVEN TO AVOIDING ANY INJURY TO THE VAGUS NERVE, AND CRURAL CLOSURE SHOULD BE PERFORMED IN ALL PATIENTSIN THE SERIES, FAILURE OF THE PROCEDURE HAS BEEN RELATED TO WEAK CRURAL MUSCLES, LARGE SIZE OF THE HIATAL HERNIA, SLIPPED NISSEN, OR SUTURE BREAK. SEVERE BUCKING DURING EXTUBATION, VOMITING, AND SNEEZING DURING THE IMMEDIATE POSTOPERATIVE PERIOD MAY HAVE CONTRIBUTED TO TWO FAILURES IN THE SERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129898 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention